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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K950388
Device Name POLARIS
Applicant
Spegas Industries, Ltd.
7 Hamarpeh St., P.O. Box 45025
91450 Jerusalem,  IL 91450
Applicant Contact SAAN BROWN
Correspondent
Spegas Industries, Ltd.
7 Hamarpeh St., P.O. Box 45025
91450 Jerusalem,  IL 91450
Correspondent Contact SAAN BROWN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/01/1995
Decision Date 05/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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